Documentos de Académico
Documentos de Profesional
Documentos de Cultura
16-01249-EN-01
January 2015
LEGAL MANUFACTURER
BK Medical Aps
Mileparken 34
2730 Herlev
Denmark
Tel.:+45 4452 8100/Fax:+45 4452 8199
www.analogicultrasound.com
Email: info@analogicultrasound.com
The serial number label on a BK Medical product contains information about the year of manufacture.
BK Medical Customer Satisfaction
Input from our customers helps us improve our products and services. As part of our customer
satisfaction program, we contact a sample of our customers a few months after they receive their orders.
If you receive an email message from us asking for your feedback, we hope you will be willing to
answer some questions about your experience buying and using our products. Your opinions are
important to us. You are of course always welcome to contact us via your BK Medical representative or
by contacting us directly.
If you have comments about the user documentation, please write to us at the email address above. We
would like to hear from you.
System Software
NOT FAULT TOLERANT. THE SOFTWARE IS NOT FAULT TOLERANT. BK Medical HAS
INDEPENDENTLY DETERMINED HOW TO USE THE SOFTWARE IN THE DEVICE, AND MS HAS
RELIED UPON BK Medical TO CONDUCT SUFFICIENT TESTING TO DETERMINE THAT THE
SOFTWARE IS SUITABLE FOR USE.
EXPORT RESTRICTIONS. You acknowledge that Windows 8 Embedded is of US-origin. You agree to comply
with all applicable international and national laws that apply to Windows 8 Embedded, including the U.S. Export
Administration Regulations, as well as end-user, end-use and country destination restrictions issued by U.S. and
other governments. For additional information on exporting Windows 8 Embedded, see http://
www.microsoft.com/exporting/
The bk3000 Ultrasound System is closed. Any modification of or installation of software to the system may
compromise safety and function of the system. Any modification of or installation of software without written
permission from BK Medical will immediately void any warranty supplied by BK Medical. Such changes will also
void any service contract and result in charges to the customer for restoration of the original bk3000 Ultrasound
System.
Trademarks:
DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications
relating to digital communications of medical information.
Microsoft and Windows are registered trademarks of Microsoft Corporation in the United States and other countries.
Contents
Chapter 1
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Modes of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Chapter 2
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Safety Symbols and Information on the Equipment . . . . . . . . . . . . . . . . . . . . . . . 9
General Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Mechanical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Explosion Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Electrical Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
ESD Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Electrical Noise. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
RF (Radio Frequency) Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Connecting Other Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Network Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Network Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Network Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
EMC Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Isolation of DICOM Network. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Wireless Networks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Medical Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Non-Medical Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Computer Security. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Service and Repair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
During an Examination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Checking the Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Verifying the Transducer Type. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
VFI - Vector Flow Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Puncture and Brachytherapy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
3D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Picture in Picture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Acoustic Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Monitor Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Thermal and Mechanical Indices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Chapter 3
Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Appendix A
English source version
16-01249-EN-01
Chapter 1
General Information
This user guide is for the bk3000 ultrasound system.
NOTE: Some of the functionality and options described in this guide may not be
Information
Getting Started
User interface, basic operating instructions. Note: this book is part of the
system user guide.
Failure to follow safety instructions or use for purposes other than those described in
the user manuals constitutes improper use.
Essential Performance
The system can provide 2D and 3D ultrasound echo and flow imaging systems as an
aid in diagnosis, data processing and -transfer, and guidance of puncture and biopsy.
The system can perform simple geometric measurements and calculations.
The system can guide biopsy- and puncture needles.
The system is free from artefacts or distortion in the image or error of a displayed
value, which can be attributed to a physiological effect and which may alter the
diagnosis.
General Information
The system displays correct numerical values associated with the diagnosis to be
performed.
The As Low As Reasonably Practicable (ALARP) principle is used and safety
related indications (MI, TIS, TIB, etc) are displayed as worst-case values.
The system does not generate unintended or excessive ultrasound output or
transducer surface temperature.
There is no unintended or uncontrolled motion of transducer assemblies intended for
intra-corporeal use.
Intended Use
The system is intended for diagnostic ultrasound imaging or fluid flow analysis of
the human body, data processing and guidance of puncture and biopsy.
The system performs simple geometric measurements and calculations in the
following areas:
Urology
Vascular
Cardiology
OB/GYN
Modes of Operation
1. In the USA, contrast-enhanced ultrasound has not been market cleared by the FDA, with the
exception of select cardiac imaging applications.
2. CW Doppler on the bk3000 has not been market cleared by the FDA or licensed by Health
Canada.
3. Elastography on the bk3000 has not been market cleared by the FDA or licensed by Health
Canada.
6 Chapter 1
January 2015
Indicated uses are different for different transducers. The Product Data sheet for the
system contains a table listing the indicated uses for each transducer that can be used
with the system.
Contraindications
The bk3000 ultrasound system is not intended for ophthalmic use or any use
causing the acoustic beam to pass through the eye.
The Cardiac Adult application is not intended for direct use on the heart.
General Information
8 Chapter 1
January 2015
Chapter 2
Safety Information
The system can be used for continuous operation, but imaging duration for individual
patients must not exceed 60 minutes. We recommend, however, that you turn off the
system at the end of each workday.
Safety Information
This user guide contains cautions, warnings and other information about what you
must do to ensure the safe and proper performance of the ultrasound system. You
must also follow local government rules and guidelines at all times.
WARNING
Warnings contain information that is important for avoiding personal injury.
Caution
Cautions contain information and instructions that must be followed to avoid
damaging equipment, data, or software.
NOTE: Notes contain information that you should be aware of.
Name
Description
Caution or Warning
Pushing prohibited
Safety Information
Symbol
3D56
Name
Description
Manufacturer
Legal manufacturer.
UL Classification for
Canada and US
Rx only
Potential
Equalization
Ground (earth)
Type BF
Type BF
BF, defibrillator-proof
Type B
Sealing
Standby
ESD (electrostatic
discharge)
WEEE waste
10 Chapter 2
January 2015
The system also complies with ANSI/AAMI ES60601-1 (2005) and CAN/CSA
C22.2 No.601.1 (2008).
It fulfills the requirements for dust protection (IP20) for ordinary equipment
specified in EN 60529.
Caution Rx-c1
Physicians
only
Federal law in North America restricts this device to sale to, or on the order of, a
physician.
WARNING GS-w1
Proper
Training
WARNING GS-w2
Equipment
failure
If at any time the system malfunctions, or the image is severely distorted or degraded, or
you suspect in any way that the system is not functioning correctly:
Remove all transducers from contact with the patient.
Turn off the system. Unplug the system from the power source.
Do not try to repair the system yourself.
Contact your BK Medical representative or hospital technician.
WARNING GS-w3
Isolating the
system
The power supply cord connects the equipment to the line voltage. To isolate the
equipment, you must unplug the power supply cord from the power source. Do this
before you try to make any repairs to the system.
Caution S-c2
Spilled
liquids
Caution S-c3
Condensation
Large variations in temperature or humidity may cause water to condense inside the
system. If this happens, the system may fail to operate properly. Always let the system
come to room temperature before you plug it in.
Wait at least 2 hours after the system has been subjected to major changes in
temperature or humidity.
If there is visible evidence of condensation, wait at least 8 hours.
Safety Information
11
Before you use the equipment, make sure that all the safety requirements described
in this chapter have been satisfied.
Mechanical Safety
Mechanical failure or unintended use of ultrasound equipment can result in physical
injury to patients or operators.
WARNING MS-w1
Mechanical
injury
WARNING MS-w2
All parts
must be
stable
When parts of the equipment can be mounted individually (for example, for use in an
operating room) each part must be securely mounted to a stable support so that it does
not tip, fall or come loose and injure someone.
WARNING MS-w3
Dont drop
the scanner
unit
To avoid personal injury or damage to the system, if you handle the scanner unit by itself,
make sure you have a firm grip so that you do not drop it. Note that it may be hot.
WARNING MS-w4
Dont push
too hard
To avoid injury and equipment damage, do not push the system too hard, especially when
you roll the system over an uneven surface. Applying excessive force near the top could
cause the system to overbalance and tilt.
Explosion Hazards
WARNING EH-w1
Explosion
hazards
12 Chapter 2
January 2015
Electrical Safety
WARNING ES-w1
Do not use a
power strip
Do not plug the equipment into an ordinary power strip. If the ground connection fails,
this is dangerous because
the total leakage current for all the connected equipment can exceed the limits
specified in EN/IEC 60601-1 (Part 1: General requirements for safety).
the impedance of the ground connection could exceed the limits specified in EN/IEC
60601-1.
WARNING ES-w3
Electrical
shock
You risk electrical shock if you try to get inside the equipment (other than opening a cover
to access connectors or batteries described in the user guide). Do not allow anyone but
qualified service personnel to service the equipment.
ESD Training
The ESD Symbol
Anyone using the equipment must be able to recognize the ESD symbol and
understand how to take the necessary precautionary procedures, as described in the
caution below.
Caution ESD-c1
ESD
Interference
The 2300 Ultrasound System is suitable for use in all establishments, other than
domestic establishments and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic purposes.
Electrical Noise
WARNING EN-w1
Electrical
noise
Electrical noise from nearby devices such as electrosurgical devices or from devices that
can transmit electrical noise to the AC line may cause disturbances in ultrasound images.
This could increase the risk during diagnostic or interventional procedures.
Safety Information
13
Electromagnetic Interference
Medical electrical equipment requires special precautions regarding EMC
(electromagnetic compatibility). You must follow the instructions in this chapter
when you install the system and put it into service.
If the image is distorted, it may be necessary to position the system further from
sources of electromagnetic interference or to install magnetic shielding.
WARNING EMC-w1
Other
equipment
nearby
Do not use this equipment adjacent to other equipment. If you must place it next to or
stacked with other equipment, verify that it operates normally there and neither causes
nor is affected by electromagnetic interference.
EMC noise can reduce the usable image depth. Therefore, to avoid having to repeat
an ultrasound examination, you must make sure beforehand that the ultrasound
system can be used for the examination. Repeating an examination can be regarded
as a potential risk that should be avoided, especially if the examination involves
transducers used intracorporeally or transducers used for puncture.
Other equipment may interfere with the system, even if that other equipment
complies with CISPR (International Special Committee on Radio Interference)
emission requirements.
Caution Inter-c2
Use specified
equipment
only
14 Chapter 2
Caution: If you use accessories, transducers or cables with the system, other than those
specified, increased emission or decreased immunity of the system may result.
January 2015
Installation
WARNING I-w1
Installation
safety
requirement
To ensure safe performance, a qualified electrician or hospital safety personnel must verify
that the equipment is correctly installed and that it complies with the following safety
requirements:
Use only the original power supply cord. In the USA, this is fitted with a hospital grade
three-prong grounded power plug. Never try to remove or change the plug on the
power supply cord.
All equipment must only be connected to a grounded AC power supply (or wall outlet)
that meets EN/IEC/NEC requirements or applicable local regulations. The examination
rooms grounding system should be checked regularly by a qualified electrician or
hospital safety personnel.
Never use extension cords. The increased length of the cord will increase the resistance
of the protective ground conductor and may increase the equipments leakage current
beyond an acceptable level.
Keep power cords, sockets and plugs clean and dry at all times.
Make sure that the power supply cord cannot be accidentally disconnected from the
power source or the equipment.
Original
power cords
If the original power cords are missing or damaged, you must order new ones from
your local BK Medical representative.
Safety Information
15
WARNING C-w1
Connection
guidelines
Follow the guidelines in EN60601-1-1 (Safety requirements for medical electrical systems)
when you connect the system to other equipment.
Network Connection
BK Medicals range of ultrasound systems comply with the DICOM standard for
handling, storing, printing and transmitting information in medical imaging.
DICOM includes a file format definition and a network communication protocol
which facilitates the exchange of data between electronic medical systems.
For detailed information about:
network requirements
network configuration
workflow between devices
technical specifications
safety specifications
Network Security
It is the responsibility of the on-site personnel or technician to maintain the ITnetwork and identify, analyze, evaluate and control new risks caused by a change in
the network configuration.
If the applicable network connection does not meet the required characteristics of the
IT-network, the following hazardous situations may occur:
Corrupt patient data due to network errors, see Warning Exam-w3 on page 26
System is unable to use the network due to faulty or overloaded network, see
Warning GS-w1 on page 11
Network
guidelines
Network Printing
For printing on network printers, BK Medical supports protocols PCL 5, PCL 6 and
PS (Post Script).
Connectors
PC connectors for connecting the system to other equipment such as approved
printers and video equipment are located on the rear of the system. See Fig 2-3.
16 Chapter 2
January 2015
Some connectors are used by the system. Do not use connectors that are not labelled
in Fig 2-3.
More information about the connectors is in Table 2-2. Information about the cables
to use is in Table 2-4.
The bk3000 ultrasound system has four transducer sockets on the side of the system.
See Fig 2-2.
Safety Information
17
Power supply
cord goes here
18 Chapter 2
January 2015
Symbol
Connector
Additional Information
DVI-I
Composite/S-video Out
Microphone
Microphone connector
Audio In
Audio Out
4 USB 2.0 connectors, A-type
10/100/1000 Ethernet
Video Output
Although 4 different video output signal formats are available, the image quality is
not the same for all of them.
DVI gives best
image quality
To get the best image quality possible, connect your monitor or other video
equipment using the output signal that gives the highest quality image. See the list
below.
Output signal types (in order of quality, with digital DVI highest)
1
2
3
4
If you must use a cable that does not have a DVI connector, you may need to use an
adapter. Table 2-3 shows you which adapters can be used.
Safety Information
19
Cable Connectors
(in order of preference)
Adapter
2300 Connector
HDMI
Adapter needed
DVI-I
Not needed
DVI-I
DVI-D
15-pin (VGA)
DVI-I
BNC (Composite)
2 connectors
(S-video and composite)
7-pin S-video to
S-video/Composite
EMC Requirements
To fulfill EMC requirements, cables attached to the system must be shielded and no
longer than 5 m.
20 Chapter 2
January 2015
Connector name
Cable type
DVI-I
Dual link
Shielded, 5 m
S-video/composite Out
S-video
Shielded, 5 m
Audio In
Shielded, 5 m
Audio Out
Shielded, 5 m
USB 1
USB, 2.0
Shielded, 5 m
USB 2
USB, 2.0
Shielded, 5 m
USB 3
USB, 2.0
Shielded, 5 m
USB 4
USB, 2.0
Shielded, 5 m
USB 5
USB, 3.0
Shielded, 5 m
USB 6
USB, 3.0
Shielded, 5 m
10/100/1000 Ethernet
Network, CAT6E
Shielded, 5 m
Do not attach transducers and other accessories unless the user guide for the
transducer or accessory states that it can be used with this system. Attaching other
equipment may cause an increase in electromagnetic emissions or may cause the
system to be more sensitive to electromagnetic interference.
Wireless Networks1
The system can be connected to a wireless network for printing and archiving data.
A Wi-Fi dongle and a 30 cm USB 3.0 extender cable are supplied with the system.
Connect the dongle to the extender cable and insert into one of the USB 3.0
connectors (see Fig 2-3 on page 18).
1. Wi-Fi on the bk3000 has not been market cleared by the FDA or licensed by Health Canada.
Safety Information
21
To connect to a wireless network, click the Wi-Fi logo, choose the appropriate
network, and type in the password.
You only have to type in a password the first time you connect to a specific network.
When you turn on the system an attempt is made to reconnect to the network that the
system was connected to before it was turned off.
Weak vs.
strong signal
No wireless
connection
22 Chapter 2
The bars in the Wi-Fi logo represents the signal strength. The more lit bars in the
logo, the stronger the signal.
When the system is not connected to a wireless network, the Wi-Fi logo has a red X
over it.
An advanced Wi-Fi setting option is available on the system using Windows
configurations. Always follow the security procedures that have been established for
your hospital, clinic or institution, as well as national guidelines. Contact your BK
Medical service representative for more information.
January 2015
Additional characteristics
Data throughput
Latency
Integrity
Security characteristics
Spectrum management
None required
When you transmit data over a wireless network, some special considerations apply.
In particular, the network connections must be set up correctly. See Warning GS-w1
on page 11.
NOTE: The system only supports one network at a time.
If the system loses connection with the network while transmitting (for example,
because it is moved out of range of the network during a transmission), the pending
data is stored temporarily and re-transmitted when the connection is re-established.
For information on saving and printing using the DICOM protocol, see the DICOM
chapter in Flex Focus 1202 Advanced User Guide (16-01249-EN-00).
Caution: Wifi-c1
The network must be set up correctly so that data is sent to the correct location. Otherwise
data can be lost or accessed by unauthorized people.
Caution: Wifi-c2
A safe encrypted protocol for data transmission, approved by the hospital, must be used.
This is to prevent unauthorized people from getting access to the data.
Medical Equipment
WARNING ME-wS1
Power
source
Follow the guidelines in EN 6060111 (Safety requirements for medical electrical systems).
Equipment that complies with the requirements of EN/IEC 606011 (Part 1: General
requirements for safety) ANSI/AAMI ES60601-1 or CSA C22.2 No. 601.1M90 can be
connected to the system, but one of the following conditions must be fulfilled:
Each piece of equipment is plugged directly into an independent wall power outlet.
or
The system and other equipment are plugged into an external common isolation
transformer to control the leakage current during a ground connection fault.
Safety Information
23
WARNING ME-w2
Printers and
auxiliary
power outlet
ON/Standby
button does
not turn off
outlet
An approved printer, specified in the Product Data sheet, can be connected to the internal
auxiliary power outlet on the system. Do not use the auxiliary power outlet on the bk3000
ultrasound system for any other equipment.
The auxiliary power outlet is still live even when the ON/Standby button on the system is
turned off. To remove voltage from this outlet, you must unplug the power supply cord
from the power source.
Non-Medical Equipment
WARNING NME-w1
Follow the guidelines in EN 6060111 (Safety requirements for medical electrical systems).
If you connect non-medical equipment (instruments that do not comply with safety
requirements for medical equipment, such as a video monitor, video recorder, endoscopic
camera control unit or other documentation device), this equipment must be placed
outside the patient environment (1.5m from the bed, for example). The equipment must
fulfill the relevant EN standard or other applicable national or international standard.
One of the following conditions must be fulfilled:
The system and other equipment are plugged into an external common isolation
transformer to control the leakage current during a ground connection fault.
or
The system is grounded with an additional safety ground connection (see Additional
Protective Ground and Potential Equalization on page 15).
Computer Security
When the 2300 Ultrasound System is connected to a hospital network, BK Medical
does not take any responsibility for computer viruses from the network that may
infect the bk3000.
Caution CS-c1
Check
external
media
24 Chapter 2
You must perform a virus check on any external storage medium (USB device or DVD) to
make sure that it is virus-free before you connect it to the system.
January 2015
Authorized
personnel
Transducers
WARNING T-w1
Electrical
shock
The transducer sockets contain terminals with 3.3V. Do not touch the patient while you
are touching an uncovered socket.
WARNING T-w2
Type B
transducers
When using Type B (non-isolated) transducers, carefully check all electrical equipment
within the patient area. Also, consider using additional protective grounding.
WARNING T-w3
Electrical
burns
Do not leave transducers in contact with the patient when using HF electrosurgical
equipment.
BK Medical transducers fulfill EMC requirements when they are outside as well as
inside the patients body.
WARNING T-w4
Surface
temperature
on array
Do not turn the transducer on and allow it to scan into mid-air without ultrasound gel
applied to the surface of the array. Doing so may cause the surface temperature on the
array to heat up to 27 C above room temperature (measured according to EN 606012
37 (Particular requirements for the safety of ultrasonic medical diagnostic and monitoring
equipment)). To avoid this, freeze the image when the transducer is not used for imaging.
During an Examination
Checking the Date
Before you start imaging, verify that the date and time displayed on the monitor are
correct.
WARNING Exam-w1
Date
An incorrect date or time will make documentation of the image incorrect and may also
cause some calculated values to be incorrect.
Safety Information
25
WARNING Exam-w2
Patient ID
required
You must enter a new patient ID before you image a new patient. Otherwise the
documentation will not contain the correct patient identification, and you will not be able
to capture images and clips. We recommend that you enter the complete name of the
patient.
WARNING Exam-w3
Verify
patient ID
Before you start to image, verify that the type number on the transducer matches the
number displayed on the monitor. In case of any inconsistency, stop imaging, turn off the
system, and contact your local BK Medical representative.
Measurements
Pay careful attention when you position cursors to make measurements on a scanned
image or on a Doppler curve.
WARNING M-w1
Polygon
measuring
tool
WARNING M-w2
Using
Doppler
curves
Drawings of Doppler curves, manual and automatic, are meant as tools for positioning
cursors so that measurements based on the curves can be calculated automatically. The
system has no facilities for checking whether the automatic measurements are
reasonable. Curves drawn on very noisy spectra may lead to misplacement of
measurement cursors. Make sure that measurement cursors are positioned so that the
results are reasonable. If they are not, you must adjust the position of the cursors manually.
Nuchal Translucency
Caution NT-c1
Nuchal
translucency
26 Chapter 2
You must be adequately trained before you attempt to make nuchal translucency
measurements.
January 2015
Before you turn on VFI, check the B-mode image to make sure there are no artifacts visible
in the blood vessel. If there are strong artifacts in the B-mode image, the arrows in VFI may
be pulled to point in a more axial direction (toward or away from the transducer),
especially in low flow situations with correspondingly low PRF. These artifacts will not
affect the color mode (CFM) image, so it is important to check in B-mode.
WARNING VFI-w2
Arrow
aliasing
Check to make sure the VFI arrows are not aliasing before you activate the assisted
Doppler gate placement. Otherwise, the Doppler gate will not be positioned correctly.
WARNING VFI-w3
Diameter
markers
Check to make sure that the diameter markers correspond to the inner vessel wall and that
the connecting line between the markers is perpendicular to the direction of the vessel.
Otherwise, the real-time volume flow measurement may not be precise.
WARNING VFI-w4
Doppler gate
large
enough
Check to make sure that the Doppler gate covers the entire vessel. Otherwise, the realtime volume flow measurement may not be precise.
WARNING VFI-w5
Doppler gate
over only
one vessel
Check to make sure that the Doppler gate only covers one vessel. Otherwise, the real-time
volume flow measurement may not be precise.
WARNING VFI-w6
Doppler
spectrum
aliasing
Check to make sure that the Doppler spectrum does not alias. Otherwise, the real-time
volume flow measurement may not be precise.
Before you start to imaging, verify that the type number or description of the puncture
attachment you are using match the number displayed on the monitor. Also make sure
that the needle guide is positioned correctly. If the numbers do not match, or if the needle
guide position is not correct, the puncture line on the monitor may not correspond to the
true puncture path in the tissue. In case of any inconsistency, stop imaging, turn off the
system, and contact your local BK Medical representative.
1. Vector Flow Imaging on the bk3000 has not been market cleared by the FDA or licensed by Health Canada.
Safety Information
27
WARNING P-w2
Verify
puncture
guide type
number
Verify that the type number of the puncture guide displayed on the monitor corresponds
to the puncture guide that you are actually using. If the number is incorrect, the puncture
line on the monitor may not correspond to the true puncture path in the tissue.
WARNING P-w4
Watch the
needle tip
The puncture line on the image is an indication of the expected needle path. The needle
tip echo should be monitored at all times so any deviation from the desired path can be
corrected.
NOTE: If the image depth is set very low (to see tissue close to the transducer with
high magnification), the needle tip echo can be outside the displayed image area. To
see the needle tip in this case, zoom out so the full needle path is visible or pan the
image to the side (to keep the high magnification).
WARNING P-w3
Offset
changes
Changes you make to the offset of a programmable puncture guide or brachy matrix will
affect ALL programmable puncture guides and brachy matrixes. This could lead to
incorrect puncture lines or matrix positions for a different guide than the one you wanted
to change.
Verify that the matrix type and coordinates displayed on the monitor agree with the actual
matrix template you are using.
WARNING B-w2
Verify userdefined
matrix
If you create a user-defined matrix, it is your responsibility to verify that the matrix that
appears on the monitor corresponds to the physical matrix you are using.
WARNING B-w3
Verify matrix
alignment
Before you use the matrix for seed implantation or biopsy, check the matrix offset value to
verify that it corresponds with the chosen matrix. Then check the matrix alignment. See
Care, Cleaning & Safety for instructions.
3D
Pay particular care to the following safety issues when operating the 3D system.
28 Chapter 2
January 2015
WARNING 3D-w2
Untracked
freehand
You cannot make accurate measurements on a 3D data set acquired using the untracked
freehand method.
If you start to make a measurement on a 3D data set acquired using the untracked
freehand method, the following warning appears on the monitor:
Warning on
monitor
Symbol
Description
Measurement will not be accurate.
Picture in Picture
WARNING PIP-1
PiP must not
cover
important
information
When you use Picture in Picture, do not cover critical information (such as TI or MI) on the
monitor. Make sure that all important information will appear if you print or save the
ultrasound image.
Acoustic Output
General
Medical research has yet to prove whether or not ultrasound causes biological
effects. Therefore, prudent use considerations require you to follow certain
guidelines; see EN60601-2-37 (Particular requirements for the safety of ultrasonic
medical diagnostic and monitoring equipment).
Prudent Use
WARNING AO-w1
Exposure
level
Always keep the exposure level (the acoustic output level and the exposure time) as low as
possible.
Safety Information
29
WARNING AO-w2
Appropriate
transducer
To avoid tissue damage, always use the transducer best suited to the examination.
Acoustic output data for transducers used with the system are given in the Technical
Data (BZ2100) that accompanies this user guide. The uncertainty level for each
parameter is also listed. For definitions of the parameters, refer to the Food and Drug
Administration (FDA) Guide as well as EN 60601-2-37 (Particular requirements for
the safety of ultrasonic medical diagnostic and monitoring equipment) and
AIUM/NEMA standards.
The routes (or tracks) available for clearance by the FDA are well-defined. Track 3
is for diagnostic ultrasound systems that follow the Output Display Standard. Under
Track 3, acoustic output will not be evaluated on an application-specific basis, but
the maximum derated Spatial PeakTemporal Average Intensity (ISPTA) must be
720mW/cm , the maximum Mechanical Index (MI) must be 1.9, and the
maximum Thermal Index (TI) must be 6. All BK Medical transducers for use with
the 2300 Ultrasound System are Track 3.
2
Monitor Display
The Mechanical Index (MI) and Thermal Index (TI) can be viewed in all imaging
modes.
30 Chapter 2
January 2015
MI Formula
P r0,3 z sp
MI = -----------------------fc
Definition
Pr0.3(zsp)
fc
TI Formula
W0
TI = -----------W deg
Blood
perfusion and
TI
Fever
W0
Wdeg
estimated power necessary to raise the temperature of the target tissue one
degree Celsius (W/C)
As a rule of thumb, the Thermal Index (TI) indicates the highest expected
temperature increase in degrees Celsius. It is based on an average level of blood
perfusion. The displayed TI may underestimate the temperature rise in poorly
perfused tissues; you must take this into account when deciding on the maximum TI
you will allow. Conversely, in areas with a rich perfusion of blood the temperature
increase will be less than the displayed TI indicates.
A temperature increase of one degree Celsius increase in a patient with fever may
cause complications in certain circumstances; it may be safer to delay the
investigation.
I = I w exp 0,069fz
distance (in cm) from the transducer face to the position where I is maximum
Safety Information
31
It should be stressed that the in situ values given are only applicable when there is
attenuating tissue between the transducer face and the focal point.
Current scientific and clinical concern over possible adverse effects is particularly
focused on fetal ultrasound imaging. It is due to the increased sensitivity of
mammalian cells and organs at this phase of their development and the fact that such
a risk could have profound implications on public health. If you use high acoustic
output levels for some reason (see Functions Affecting Acoustic Output, below),
be sure to return to B-mode alone and turn down the power level before you do any
fetal imaging.
The user can set a Thermal Index limit. This will provide an upper limit for acoustic
output.
32 Chapter 2
January 2015
These setups have been optimized to give the best compromise between low acoustic
output and enough power to obtain the image features as quickly as possible. This is
part of the ALARA principle. The factory default setup for all transducers is B-Mode
to ensure the lowest acoustic output when you start imaging.
When you enter a new patient ID, by default the transducer setup will be reset to the
factory setup.
Fetal imaging
When you use transducers intended for fetal imaging, it is important to make sure
that the default settings are appropriate and to reset to the default setting before
imaging a new patient.
The sound velocity may vary from approximately 1450 m/s in fatty tissue to
1585 m/s in muscle. This can, in simple cases, give rise to errors of up to 6% for
linear measurements. This inaccuracy may be further increased by refraction
occurring at tissue boundaries.
The user can introduce errors when using approximate formulas, when
positioning the systems calipers with respect to the ultrasound image and when
outlining structures in the image.
The ellipsoid volume approximation, described in this user guide, is only
applicable when the cross section of the structure being studied approximates an
ellipse (the circle being a special ellipse), and when the structure is roughly
symmetrical about the selected axis of rotation
NOTE: The choice of the axis of rotation is important for the calculation of the
Safety Information
33
Figure 2-6. The dotted line indicates the convex hull of the non-convex figure.
Geometric Measurements
2D Measurements
The geometric measurements performed by BK Medical ultrasound systems are
distance, perimeter, area and ellipsoid volume. The accuracy of these measurements
is influenced by the following factors:
Transducer geometry
Rounding of results
Resolution of digital image memory
3D Measurements
The 3D volume is found by summing the marked area in the individual slices and
multiplying by a factor that includes the distance between the slices and their relative
orientation.
To obtain the accuracies listed in the table in the Technical Data (BZ2100), you must
ensure that the calculation is based on contributions from at least 10 slices for very
regular shapes and more for irregular shapes. It must also be possible to discriminate
the boundary of the object from the surrounding tissue.
Volume
accuracy
The volume accuracy in the table is given as a percentage of the captured 3D volume
starting with the first slice and ending with the last slice that intersects the object of
interest.
If the 2D ROI (region of interest) is set to be much larger than the object, the accuracy
as a percentage of the object volume can be much worse (higher percent).
NOTE: To ensure that the accuracy of your volume measurement is as high as
possible, make sure that the object you are interested in fills the region of interest as
much as possible.
Distance and
area accuracy
34 Chapter 2
The accuracy of a distance measurement on a 3D image will never be better than 6%;
the accuracy of an area measurement on a 3D image will never be better than 6%.
January 2015
In the table in the Technical Data (BZ2100), the overall measurement accuracy for a
full range measurement is given in the right-hand column for each measurement. The
footnote below the table states the digital image resolution.
Time Measurements
In M-mode and spectral Doppler mode, data is displayed along a time axis. It is
possible to measure time differences. The accuracy for a time difference
measurement is
Doppler Measurements
In measuring blood flow velocity it is assumed that the measured power spectral
distribution of the Doppler signal equals the blood cell velocity distribution.
The measurement accuracy of blood flow velocity is heavily dependent on the angle
between the ultrasound beam and the velocity vector of the blood cells. The
velocity accuracies given in the Technical Data (BZ2100) are valid for = 55. To
find the percentage accuracy for other angles, multiply the stated accuracy by
cos cos + 1,8
----------------------------------------------- 100 + 0,5
cos
If the blood velocity exceeds the selected velocity range, aliasing occurs,
corresponding to an overload condition of the measurement system.
Safety Information
35
36 Chapter 2
January 2015
Chapter 3
Getting Started
Getting Started with bk3000 forms part of this user guide.
Getting Started
37
38 Chapter 3
January 2015
Index
Numerics
3D
A
accuracy
2D geometric measurements 34
3D distance 34
3D measurements 34
3D volume 34
clinical measurements explained 33
Doppler measurements 35
time difference measurements 35
acoustic output
default 32
factors affecting 32
measurement 3132
ALARA principle 30, 33
auxiliary power outlet 24
B
biopsy. See puncture.
brachytherapy
warning about checking matrix 28
warning about user-defined matrixes 28
warning to verify matrix type and coordinates 28
brightness, adjusting monitor. See Getting Started.
C
caution or warning, symbol 9
Cautions
about 9
displayed on the system 43
center frequency 31
connectors for other equipment
accessing 16
location 16
picture 18
consult instructions for use (symbol) 9
contraindications 7
D
DICOM
conformance statement 16
connection if network is not isolated 21
network isolator 21
standard 16
disposing of the system 10
distorted image 14
Doppler measurements
accuracies 35
warnings 26
Doppler mode
fetal imaging 33
F
fetal imaging, acoustic output settings for 33
G
ground (earth), additional protective
adding 15
symbol 10
H
height, adjusting. See Getting Started.
HF electrosurgical equipment, warning 25
I
image distortion 11, 14
indications for use 7
installation 15
intended use 6
isolation from line voltage 11
K
keys (basic), overview. See Getting Started.
L
leakage current 13, 23, 24
liquids, do not spill on system 11
M
magnetic shielding 14
manufacturer (symbol) 10
measurements, Doppler warnings 26
medical equipment
39
connecting to system 23
MI (Mechanical Index)
and ALARA 30
formula 31
modes of operation 6
monitor brightness, adjusting. See Getting Started.
N
network
guidelines 16
isolator 21
printing, protocols for 16
network security
guidelines 16
responsibility for 16
noise
electrical 13
EMC 14
non-medical equipment, connecting to system 24
O
on and off, turning system. See Getting Started.
ON/Standby button
symbol on 10
warning 24
overbalance and tipping
warning 12
warning symbol 9
P
patient ID
importance of entering 26
verifying 26
Peak Rarefactional Pressure 31
potential equalization
symbol 10
terminal 15
power cord
keep clean and dry 15
original 15
power plug 15
power strip, do not use 13
power supply cord
accidental disconnection 15
use original 15
prostate transperineal biopsy
warning about checking matrix 28
warning about user-defined matrixes 28
warning to verify matrix type and coordinates 28
prudent use 29
puncture
warning about changing offset of programmable
puncture guides or brachy matrixes 28
warning to verify puncture guide number 28
warning to verify transducer type number 27
pushing prohibited, symbol 9
R
radio frequency interference. See RF interference.
RF interference 14
S
safety
electrical 13, 15
transducer 25
saving to USB. See Getting Started.
screen controls, basic, overview. See Getting Started.
sealing (symbol) 10
security, network. See network security.
service and repair 25
standby (symbol) 10
standby button. See Getting Started.
system
isolation from line voltage 11
malfunction 11
T
Technical Data (BZ2100) 5, 30, 33, 34, 35
Thermal Index limit
setting 32
Thermal Index limit, setting 32
TI (Thermal Index)
and ALARA 30
blood perfusion and 31
time measurements 35
tipping and overbalance
warning 12
warning symbol 9
training before using equipment 11
transducer sockets, warning about covering 25
transducer, electrical safety 25
transperineal biopsy
warning about checking matrix 28
warning about user-defined matrixes 28
warning to verify matrix type and coordinates 28
turning system off and on, See Getting Started.
Type B (non-isolated) transducers, warning about 25
Type B (symbol) 10
Type BF (symbol) 10
Type BF, defibrillator-proof (symbol) 10
U
UL (symbol) 10
USB, saving to. See Getting Started.
V
VFI (Vector Flow Imaging), warnings about 27
viewing an examination. See Getting Started.
virus
checking external storage media 24
from network 24
W
Warnings
about 9
displayed on the system 43
waste disposal symbol 10
WEEE waste (symbol) 10
40
Wi-Fi
connecting to 21
correct setup and safe protocol required (cautions)
23
network characteristics 23
password 22
signal strength 22
using 21
wireless network. See Wi-Fi.
41
42
Appendix A
Warnings and Cautions Displayed on the System
This appendix contains a list of warnings and cautions that may appear on the system
if you perform an undesirable action or e.g. type in a wrong setting value. Contact a
service technician if you encounter a persistent problem that can not be solved by the
suggested action(s) below.
The list also covers potential system and transducer malfunctions. Always contact a
service technician if the system or the transducer malfunctions, see Warning GS-w2
on page 11.
Warning text
Try again.
Try again.
Try again.
January 2015
43
Warning text
Continue or discontinue.
Continue or discontinue.
44 Appendix A
January 2015
Caution text
Try again.
Try again.
Try again.
Try again.
Check formula.
Try again.
45
Caution text
Try again.
Try again.
Failed to copy.
Try again.
Try again.
Try again.
Try again.
Try again.
Try again.
Try again.
Try again.
Try again.
Try again.
Try again.
Try again.
Try again.
Try again.
Try again.
Try again.
Try again.
Try again.
Try again.
46 Appendix A
Try again.
Try again.
Try again.
Try again.
January 2015
Caution text
Try again.
Try again.
Try again.
Try again.
Try again.
Import of license keys from "%s"
completed.\nThe following license keys could
not be imported:\n%s
Fill out the required fields according to the on
Invalid %s.\n\nEmpty names are not
allowed.\nNames must be shorter than %d screen instructions.
characters.\nNames must not contain any of
the following characters:\n%s
License already in use.
Login error. Please try again.
Name and description are required. Do not
leave the fields empty.
Name and formula are required. Do not leave Fill in name and formula.
the fields empty.
No catalogs available.\n\nAssign catalogs in
setup window.
No default propackage available for the %s
transducer choose a default propackage
No Preset name was specified.\nNothing will Specify a preset name.
be saved.
Only %d fields can be selected for the Patient
window. Deselect some of the fields.
Please disconnect all transducers, restart the
scanner, and start the import again.
Please enter a number
Please enter an SMTP Server Address.\nIt
must be entered as a name or an IP address.
Please insert the archive disc labeled "%s" and
try again.
47
Caution text
Try again.
Try again.
Upgrade software.
Try again.
48 Appendix A
January 2015
Caution text
Upgrade software.
Try again.
49
Caution text
The value "%s" (%s) is outside the legal range Keep value (s) within legal range.
(%.2f - %.2f).
The volume name is already used in the
patient archiving system. Please enter
another name.
The volume name is not valid. It contains only
illegal character(s). Please enter the new
volume name.
The volume name is too long. The name must
be no longer than %d characters.
The width and height must be numbers
between %d and %d.
There are no files to be burned to a CD.
There is no mail receiver (SMTP To-address)
configured.\nTechnical service must
configure this service before it can be used.
There is no USB Device connected to the
scanner.
There was a problem saving the Diagnostic
Setup %s.
Try again.
Try again.
Try again.
50 Appendix A
January 2015